Intervention for Young Adults With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— ESPRIMO  

Official title:

ESPRIMO: A Bio-psycho-social Co-created Intervention for Young Adults With Multiple Sclerosis: Study Protocol for a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04431323
• Other study ID #: 2676CESC
• Status: Completed
• Phase: N/A
• Start date: May 13, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: January 2023
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to develop - in collaboration with patients with multiple sclerosis (MS)- a psychosocial and physical activity intervention (i.e., ESPRIMO intervention) for young adults with MS targeted at improving patients' health-related quality of life (HRQoL). Further, the study seeks to preliminarily test the effect, feasibility, and acceptability of the ESPRIMO intervention using a pilot sample of young adults with MS. Given that the ESPRIMO study will be conducted immediately after the COVID-19 emergency, it does not seem reasonable to start the co-creation of the intervention without taking into account the potential impact of this pandemic on the quality of life and well-being of patients with MS and on their management of care. Thus, the investigators seek to better understand the needs of the target population under these particular circumstances.

Description:

Being the most common neurological disease causing disability in young adults, multiple sclerosis (MS) does not only impair physical functions but is also often associated with fatigue, symptoms of depression and anxiety as well as reduced health related quality of life (HRQoL). Especially the first years after the diagnosis can be emotionally challenging and psychological adjustment problematic. Since MS is generally detected between the ages of 20 and 40, a period of great significance for professional and personal development, the adaptation to this chronic disease may become even more challenging. It is now well established that psychological interventions aiming to support people with MS (e.g., Cognitive Behavioural Therapy, mindfulness-based interventions) do not only have a positive effect on psychological aspects, such as resilience, but also on physiological outcomes (e.g., fatigue, physical vitality) and on the perception of general health. According to the literature, psychological well-being and HRQoL can be also promoted by regular physical activity and exercise (e.g., walking, ballroom dancing), which present the additional advantage of reducing some physical symptoms of MS. Practicing physical activity in groups enables participants also to socialize and create interpersonal relationships, which in turn may significantly affect patients' psychological well-being and illness perception. Despite the positive impact of interventions focusing on either physical, psychological or social/interpersonal dimensions, there has been little discussion about the development of comprehensive interventions based on the bio-psycho-social model of disease. Even less attention has been paid to the development of early interventions tailored to young adults' needs and to the engagement of patients in the creation of such programs despite the fact that patient engagement has become a central priority for researchers and policy makers in medicine. Therefore, the investigators aim to develop - in collaboration with patients with MS - a psychosocial and motor intervention (i.e., ESPRIMO intervention) for young adults with MS targeted at improving patients' HRQoL. Further, the study seeks to preliminarily test the effect, feasibility, and acceptability of the ESPRIMO intervention using a pilot sample of young adults with MS. In the so-called co-creation phase, the primary aim is to create, together with patients, a bio-psycho-social intervention, following also the preferences and suggestions of healthcare professionals. In the intervention phase, the primary aim is to explore the feasibility of the intervention and its effect in improving their quality of life. Secondary aims of the study are five-fold: 1) to collect patients' opinions and needs as well as healthcare professionals' perspectives on the preferred characteristics of a bio-psycho-social intervention; 2) to explore the effect of the bio-psycho-social intervention in improving bio-psycho-social aspects, such as quality of life, resilience, fatigue (see primary and secondary outcomes) 3) to investigate potential relationships between these psychological variables at baseline and post-intervention; 4) to assess the differences in effect, patient satisfaction and participation rates according to sociodemographic and clinical characteristics; 5) to examine the reasons for dropouts and possible barriers to participation. Additionally, considering that the ESPRIMO Study will start shortly after the end of the COVID-19 emergency, the potential impact of this emergency on patients' well-being and quality of life must be taken into account when creating the intervention together with the patients. Therefore, the investigators aim to explore in a pre-phase the potential impact of the COVID-19 emergency on the psychological status and management of disease and the potential positive resources used to deal with this highly challenging situation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

As different samples of patients and healthcare professionals will be enrolled in the

different phases of the studies, inclusion and exclusion criteria vary:

1. Explorative pre-phase "Exploring the psychological impact of the COVID-19 emergency"

Inclusion Criteria:

• age range: 18-45 years;
• MS Diagnosis;
• Italian speakers;
• electronic informed consent signed.

Exclusion Criteria:

• N/A

2. Co-creation phase - Survey with young adults with MS

Inclusion Criteria:

• age range: 18-45 years;
• MS diagnosis;
• Italian speakers;
• electronic informed consent signed. Exclusion Criteria: -N/A

3. Co-creation phase - Survey with Healthcare Providers

Inclusion Criteria:

• being a healthcare professional working with MS patients;
• Italian speakers;
• electronic informed consent signed. Exclusion Criteria: -N/A

4. Co-creation phase - Focus groups

Inclusion Criteria:

• age range: 18-45 years;
• MS diagnosis;
• Italian speakers;
• signed informed consent. Exclusion Criteria: -N/A

5. Intervention phase

Inclusion Criteria:

• age range: 18-45 years;
• Ms diagnosis according to the revised McDonald Criteria [Thompson et al., 2018];
• Italian speakers;
• Signed informed consent.

Exclusion Criteria:

• clinically relevant cognitive deficits as evaluated by the treating neurologist which may represent obstacles in filling the questionnaires and participating in the intervention;
• severe psychiatric disorders, such as psychosis, bipolar disorder, active substance abuse problems, dissociative disorders, or a current diagnosis of major depression as evaluated by the neurologist or the clinical psychologist;
• clinically relevant physical impairments rendering impossible the physical activities included in the intervention, defined as an Expanded Disability Status Scale (EDSS) score higher than 3.5 [Bowen et al., 2001].

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• ESPRIMO
Participants will receive the intervention during Phase 2. The intervention is based on the cognitive behavioral, the third-wave (mindfulness and acceptance and commitment therapy), and the positive psychology approach. The frequency of the intervention and the specific content and aims of the psychological and physical intervention will be based on the results of the surveys and the focus group discussion (Pre-phase and Phase 1). In order to maximize the benefit of the integrated intervention, all the three components of the interventions (i.e., psychological, motor exercise and social components) will be administered in the same time period. A preliminary theoretical framework of the intervention will be created prior to the survey phase according to the literature in the field. Specific aspects of this preliminary framework will be discussed during the co-creation phase and adapted after the analysis of the qualitative results.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Integrata Verona, Policlinico G.B. Rossi	Verona	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

References & Publications (22)

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Bonino S, Graziano F, Borghi M, et al. The Self-Efficacy in Multiple Sclerosis (SEMS) Scale: Development and Validation With Rasch Analysis. European Journal of Psychological Assessment. 2015; doi: 10.1027/1015-5759/a000350.

Bowen J, Gibbons L, Gianas A, Kraft GH. Self-administered Expanded Disability Status Scale with functional system scores correlates well with a physician-administered test. Mult Scler. 2001 Jun;7(3):201-6. doi: 10.1177/135245850100700311. — View Citation

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Costantini M, Musso M, Viterbori P, Bonci F, Del Mastro L, Garrone O, Venturini M, Morasso G. Detecting psychological distress in cancer patients: validity of the Italian version of the Hospital Anxiety and Depression Scale. Support Care Cancer. 1999 May;7(3):121-7. doi: 10.1007/s005200050241. — View Citation

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Pain D, Miglioretti M, Angelino, E. Development of Italian version of brief-IPQ (Illness perception questionnaire, short version), a method for assessing the illness representations. Psicologia della Salute. 2006. 81-89.

Penner IK, Raselli C, Stocklin M, Opwis K, Kappos L, Calabrese P. The Fatigue Scale for Motor and Cognitive Functions (FSMC): validation of a new instrument to assess multiple sclerosis-related fatigue. Mult Scler. 2009 Dec;15(12):1509-17. doi: 10.1177/1352458509348519. Epub 2009 Dec 7. — View Citation

Prezza M, Principato MC. La rete e il sostegno sociale. In: Prezza M, Santinello M, eds. Conoscere la comunit . Bologna. Italy: Il Mulino, 2002: 193-233.

Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Health-related Quality of Life up to 1 week post-intervention	Health-related Quality of Life at 1 day post-intervention will be Health-related quality of life will be measured by the Italian version of the "Coop/Wonca charts" [van Weel et al., 1993] at baseline and 1 day post-intervention assessing the changes between the two time points.; The Coop/Wonca questionnaire is a self-reported single-item scale to explore HRQoL, including physical (fitness and daily activities), mental (emotions), social domains (social contacts) and above that general health and change in health status [Weel et al., 1995]. Each chart consists of a single question referring to the preceding two weeks and are scored on a 5-level ordinal scale ranging from 1 (no impact) to 5 (high impact), illustrated by a simple picture.	T0: baseline, T1: up to 1 week post-intervention
Primary	Acceptance and Satisfaction with the Intervention assessed by an ad hoc questionnaire	An ad hoc questionnaire (one of the two specific outcome measures evaluating the feasibility of the intervention) using closed (rated by Likert scales ranging from 1 (not at all) to 10 (very much, with higher scores reflecting higher levels of acceptance and satisfaction) and open questions will be administered to evaluate the acceptance and satisfaction of participants.; Information on participants' experience will inform the intervention and its administration and will reduce barriers to participation for future patients.	T1: up to 1 week post-intervention
Secondary	Change from Baseline Resilience Features up to 1 week post-intervention	Resilience will be measured using the Italian version of the "Connor-Davidson Resilience Scale" [CD-RISC; Connor & Davidson, 2003] at baseline and 1 day post-intervention assessing the changes between the two time points.; The CD-RISC is designed to assess resilience features in adolescents and adults and composed of 25 items and evaluated on a 5-point Likert scale (ranging from 0 "not true at all" to 4 "true nearly all of the time"), with higher scores reflecting higher levels of resilience.	T0: baseline, T1: up to 1 week post-intervention
Secondary	Change from Baseline Well-being up to 1 week post-intervention	Well-being will be measured using the Italian version of the "Short Form 12 general health questionnaire" [SF12, Apolone et al., 2001] at baseline and 1 day post-intervention assessing the changes between the two time points.; The SF12 is a validated 12-item questionnaire with Physical and Mental Component Summary (PCS and MCS, respectively) scores.; The SF12 uses different types of scales (e.g., Yes/No questions, scales ranging from 1(always) to 6 (never)).	T0: baseline, T1: up to 1 week post-intervention
Secondary	Change from Baseline Mindfulness Traits up to 1 week post-intervention	Mindfulness traits will be assessed using the Italian version of the "Five Facet Mindfulness Questionnaire" [FFMQ; Baer et al., 2006; Giovannini et al., 2014] at baseline and 1 day post-intervention assessing the changes between the two time points.; The FFMQ-SF is a 24-item self-report questionnaire measuring one general mindfulness factor and five secondary facets (i.e., Observe, Describe, Act with Awareness, Nonjudge, and Nonreact) on a 5-point Likert scale, ranging from 1 ("never or very rarely true") to 5 ("very often or always true"), with higher total scores reflecting a greater degree of mindfulness.	T0: baseline, T1: up to 1 week post-intervention
Secondary	Change from Baseline Self-efficacy in MS up to 1 week post-intervention assessed by the "Self-Efficacy in Multiple Sclerosis Scale" (SEMS)	Self-efficacy will be measured using the "Self-Efficacy in Multiple Sclerosis Scale" [SEMS; Bonino et al., 2016] at baseline and 1 day post-intervention assessing the changes between the two time points.; It is a 15-item self-completion instrument using a 5-point Likert scale (from 0 = not at all confident to 4 = very confident). Items are conceptually allocated to two areas: "Goal setting" (9 items) and "Symptom management" (6 items).	T0: baseline, T1: up to 1 week post-intervention
Secondary	Change from Baseline Perceived Social Support up to 1 week post-intervention	Perceived social support will be measured using the "Multidimensional Scale of Perceived Social Support" [MSPSS; Prezza & Principato, 2002; Zimet et al., 1988] at baseline and 1 day post-intervention assessing the changes between the two time points.; It is a 12-item self-report measure, assessing on a 7-point Likert scale (from 1 "strongly disagree" to 7 "strongly agree") the level of perceived social support of various sources: family, friends, and significant others.	T0: baseline, T1: up to 1 week post-intervention
Secondary	Change from Baseline Levels of Anxiety and Depression up to 1 week post-intervention	Levels of anxiety and depression will be measured using the "Hospital Anxiety and Depression Scale" [HADS; Zigmond & Snaith, 1983; Costantini et al., 1999] at baseline and 1 day post-intervention assessing the changes between the two time points.; The HADS is a brief self-report questionnaire composed of 14 items describing on a 4-point scale from 0 to 3 the levels of anxiety a person is experiencing.; HADS anxiety (HADS-A, 7 items) and depression (HADS-D, 7 items) subscale scores will be calculated, possibly ranging from 0 (no symptoms) to 21 (most severe symptoms). A HADS-A and HADS-D score of =8 indicates a high risk of anxiety and depressive disorder.	T0: baseline, T1: up to 1 week post-intervention
Secondary	Change from Baseline Illness Representations up to 1 week post-intervention	Illness perception will be measured using the "Brief Illness Perception Questionnaire" [Brief IPQ-R; Broadbent et al., 2006; Pain et al., 2006] at baseline and 1 day post-intervention assessing the changes between the two time points.; It is a 9-item self-completion instrument using a 5-point Likert scale (from "strongly disagree" to "strongly agree") providing a quantitative measurement of the components of illness representations [Leventhal et al., 1984; Leventhal et al., 1997].	T0: baseline, T1: up to 1 week post-intervention
Secondary	Change from Baseline Committed Action up to 1 week post-intervention	The construct of committed action is measured applying the Italian version of the "The Committed Action Questionnaire-8" (CAQ-8) [McCracken et al., 2015] at baseline and 1 day post-intervention assessing the changes between the two time points.; The CAQ-8, a short version of The Committed Action Questionnaire [McCracken, 2013], is an 8-item questionnaire using a 7-point Likert scale (from 0 = never true to 6 = always true).	T0: baseline, T1: up to 1 week post-intervention
Secondary	Change from Baseline Levels of (Motor and Cognitive) Fatigue up to 1 week post-intervention	Fatigue will be measured applying the "Fatigue Scale for Motor and Cognitive Functions" [FSMC; Penner et al., 2009; Elbers et al., 2012] at baseline and 1 day post-intervention assessing the changes between the two time points.; It is a self-report fatigue questionnaires validated in patients with multiple sclerosis (MS) and useful to evaluate both motor and cognitive fatigue.; It is composed by 20 items evaluated on a Likert scale, ranging from 1 (it never happens) to 5 (it always happens), with higher scores reflecting higher levels of motor and cognitive fatigue.	T0: baseline, T1: up to 1 week post-intervention
Secondary	Change from Baseline Perceived Autonomy Support up to 1 week post-intervention	Perceived autonomy support (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured with the "Perceived Autonomy Support Scale for Exercise Setting" (PASSES; Hagger et al., 2007) at baseline and 1 day post-intervention assessing the changes between the two time points.; The 12 items are rated on a 7-point Likert scale ranging from 1(totally disagree) to 7 (totally agree), with higher scores reflecting greater perceptions of autonomy support.	T0: baseline, T1: up to 1 week post-intervention
Secondary	Change from Baseline Autonomous Motivation up to 1 week post-intervention	Autonomous motivation (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured with the "Behavioral Regulation in Exercise Questionnaire" [BREQ-3; Markland et al., 2014] at baseline and 1 day post-intervention assessing the changes between the two time points.; The 24 items are rated on a 5-point Likert scale ranging from 1 (totally disagree) to 5 (totally agree).	T0: baseline, T1: up to 1 week post-intervention
Secondary	Change from Baseline Attitudes up to 1 week post-intervention	Attitudes (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured by a scale developed by Galli et al. [2018], following the recommendations of Ajzen [1991] at baseline and 1 day post-intervention assessing the changes between the two time points.; The scale comprises 6 items with responses provided on seven-points scales (with contrasting adjectives (e.g.,"bad - good", "harmful-beneficial").	T0: baseline, T1: up to 1 week post-intervention
Secondary	Change from Baseline Subjective Norms up to 1 week post-intervention	Subjective norms (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured by a scale developed by Galli et al. [2018], following the recommendations of Ajzen [1991] at baseline and 1 day post-intervention assessing the changes between the two time points.; The 3 items of the scale are rated on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree), with a greater single score (aggregated item scores) indicating greater normative social pressure toward the behavior.	T0: baseline, T1: up to 1 week post-intervention
Secondary	Change from Baseline Perceived Behavioral Control up to 1 week post-intervention	Perceived Behavioral Control (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured by a scale developed by Galli et al. [2018], following the recommendations of Ajzen [1991] at baseline and 1 day post-intervention assessing the changes between the two time points.; The 3 items of the scale are rated on a 7-point Likert scale, with a greater single score (aggregated item scores) indicating greater perceived confidence toward the behavior.	T0: baseline, T1: up to 1 week post-intervention
Secondary	Change from baseline number of steps/day to 5 days post-intervention	A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of steps/day.	T0: baseline, T1: 5 days post-intervention
Secondary	Change from baseline km traveled/day to 5 days post-intervention	A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of km traveled/day.	T0: baseline, T1: 5 days post-intervention
Secondary	Change from baseline number of active hours/day to 5 days post-intervention	A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of active hours/day.	T0: baseline, T1: 5 days post-intervention
Secondary	Change from baseline number of inactive hours/day to 5 days post-intervention	A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of inactive hours/day.	T0: baseline, T1: 5 days post-intervention
Secondary	Change from Baseline number of hours of sleep/day to 5 days post-intervention	A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of hours of sleep/day.	T0: baseline, T1: 5 days post-intervention
Secondary	Change from baseline heart rate to 5 days post-intervention	A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the heart rate (HR).	T0: baseline, T1: 5 days post-intervention
Secondary	Change from baseline heart rate variability to 5 days post-intervention	A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the heart rate variability (HRV).	T0: baseline, T1: 5 days post-intervention
Secondary	Change from estimated kilocalories consumed/day at baseline to 5 days post-intervention	A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the estimated kilocalories consumed/day.	T0: baseline, T1: 5 days post-intervention
Secondary	Number of Drop Outs	The number of drop outs is the second specific outcome measure evaluating the feasibility of the intervention.	T1: up to 1 week post-intervention
Secondary	Exact Time of Dropping Out	The exact time point of dropping out will also be assessed.	T1: up to 1 week post-intervention
Secondary	Underlying Reasons for Dropping Out assessed by an ad hoc questionnaire with open questions	Patients who drop out during the interventions will be contacted to assess the underlying reasons using an ad hoc questionnaire with open questions.	T1: up to 1 week post-intervention